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A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye

  • Clinical Investigation
  • Published:
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Abstract

Purpose

We report the clinical efficacy of sequential applications of 0.3% and 0.15% unpreserved hyaluronic acid (HA) for the treatment of dry eye disease (DED).

Study design

Randomized clinical trial.

Methods

Patients over 19 years of age with DED level 2 or higher, corneal fluorescein staining (CFS) score > 1, and tear break-up time (TBUT) < 10 s were included. Seventy-six patients were randomly assigned to the 0.15% HA group, 0.3% HA group, or combination group. Each group applied two drops of 0.15% or 0.3% HA, or a single drop of both 0.3% and 0.15% HA. Patients were evaluated using the ocular surface disease index (OSDI), CFS and conjunctival fluorescein stain score, TBUT, and blurring/discomfort after application at baseline, 4 weeks, and 8 weeks.

Results

The combination group had the greatest improvement in CFS score from baseline to 8 weeks, compared with the 0.15% and 0.3% HA group (p < 0.001). The combined CFS-OSDI responder rates of the combination group (CFS score = 0 and OSDI ≥ 50% improvement at 8 weeks) were significantly higher than those of the 0.15% and 0.3% groups (p = 0.037). At 4 and 8 weeks, blurring after application in both the 0.3% and combination groups was significantly higher than in the 0.15% group, despite no difference between the 0.3% and combination groups. There were no differences in CFS and conjunctival staining score, TBUT, or OSDI within the three groups at baseline, 4 weeks, and 8 weeks.

Conclusions

Sequential application of 0.3% and 0.15% HA improved symptoms/signs in moderate to severe DED patients.

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Acknowledgements

This work was equally supported by the National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT) (No. 2021R1A2C2013939 and 2021R1C1C1011528).

Author information

Author notes

  1. Jong Hwa Jun and Seung Pil Bang are equal contributors.

Authors and Affiliations

  1. Department of Ophthalmology, Keimyung University School of Medicine, Daegu, Republic of Korea

    Jong Hwa Jun & Seung Pil Bang

  2. Department of Ophthalmology, Kyungpook National University Hospital, Daegu, Republic of Korea

    Han Sang Park, Donghee Yoon & Hong Kyun Kim

  3. Department of Ophthalmology, Gyeongsang National University School of Medicine, Jinju, Republic of Korea

    Ja Young Ahn & Seong Jae Kim

  4. Institute of Health Sciences, Gyeongsang National University School of Medicine, Jinju, Republic of Korea

    Ja Young Ahn & Seong Jae Kim

  5. Department of Ophthalmology, School of Medicine, Kyungpook National University, #130 Dongdeok-ro, Joong-gu, Daegu, 41944, Republic of Korea

    Hong Kyun Kim

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  1. Jong Hwa Jun
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Correspondence to Hong Kyun Kim.

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Conflicts of interest

J. H. Jun, None; S. P. Bang, None; H. S. Park, None; D. Yoon, None; J. Y. Ahn, None; S. J. Kim, None; H. K. Kim, None.

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Corresponding Author: Hong Kyun Kim

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Jun, J.H., Bang, S.P., Park, H.S. et al. A randomized multicenter clinical evaluation of sequential application of 0.3% and 0.15% hyaluronic acid for treatment of dry eye. Jpn J Ophthalmol 66, 58–67 (2022). https://doi.org/10.1007/s10384-021-00885-x

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